US health officials are said to be looking to data from Israel’s military to help shed light on the safety of Pfizer/BioNtech’s COVID-19 booster jabs in young people, and the risks of developing a heart inflammation condition known as myocarditis.
The condition, while rare, has been linked to the two-dose mRNA vaccines made by Pfizer and Moderna, mostly in males under 30.
US chief medical adviser Dr. Anthony Fauci, the top US infectious disease expert, told Reuters on Friday that a key question yet to be answered was “the safety data of an mRNA in young people vis-a-vis myocarditis.”
US regulators will weigh the question and the data to determine whether to grant full approval for a booster shot in the wider population. A third jab was already approved for Americans over 65 years of age, healthcare workers, and those deemed to be at high risk of serious illness or death from COVID-19.
“The Israelis will relatively soon have that data because they’re vaccinating everybody in the country I think from 12 years old up, including their military recruits,” Fauci said. He added that the data could “help address the gap in safety information on mRNA vaccines, ‘which is one of the things that the advisory committee was interested in,'” according to the report.
On Friday, Israel’s Health Ministry released data showing that the known side effects from the COVID-19 vaccines were significantly milder from the booster shot compared to the first two doses. Reported side effects, such as fatigue, weakness, and pain in the arm where the injection was administered, were all less common the third time round in every age group, according to the ministry.
Out of some 3.2 million Israelis vaccinated with a third COVID-19 shot, just 19 reported more serious side effects, the ministry said, adding that some are still being examined by experts to determine the connection between the side effects and the vaccine.
Separately, the ministry also released data on reported cases of myocarditis among those aged 12-15 who had been administered their first and second COVID-19 vaccine dose, saying the condition was seen at an “insignificant rate.”
One case was reported out of the 331,538 children vaccinated with one vaccine dose. The boy was identified with the inflammation five days after receiving the shot, according to the ministry data. And among the 255,444 children vaccinated with two doses, 11 cases of myocarditis were reported. Ten of them were male, and one was female. They were identified with the rare condition 3-5 days after receiving the shot, the ministry said.
The ministry said that all 12 were released from hospital care to be treated at home, and the condition itself went away shortly after. It added that the chances of suffering from myocarditis are less likely in older age groups, and nearly negligible among females.
Earlier this week, Fauci said Israel’s trailblazing move to offer third vaccine doses to its population will ultimately prove justified and eventually be adopted by the US.
Fauci said US officials were receiving information from Israel on the booster shot campaign, and there was particular interest in data on young people, especially those in the Israel Defense Forces (IDF).
Speaking to Army Radio, Fauci said that in his opinion, everyone inoculated with the Pfizer vaccine would ultimately require three doses. He also agreed that this would be the case for the US population even below age 65.
“I believe so,” he said, noting that he was speaking in his personal and professional opinion, and that the decision in the US to limit booster shots to those who were 65 and up or immunocompromised had been made by committees and advisory groups. “I think ultimately there will be enough data to show that Israel is doing the right thing.”
Fauci said that he takes “very seriously” the statistics coming out of Israel. “So I am very favorably disposed to what the Israelis have done and we get a lot of good information from them,” he said.
Authorization for giving the third vaccine shot to the rest of the American population, and in particular young people, will only come when officials have assessed its safety.
But Fauci said he believes there will soon be “good safety data” on younger people receiving the third dose.
“That is why I am looking very closely when Israel gets its safety data from young individuals,” he said.
Fauci said the FDA did not reject the Israeli data indicating waning immunity against infection among all age groups around six months after vaccination, but wanted more information.
“I think they were waiting for more data from multiple cohorts, particularly in the arena of younger individuals,” he said.
“There is a great concern about the benefit-to-risk ratio of younger individuals in the context of myocarditis,” Fauci said. “We know it is a very rare event and we know that the Israelis are starting to gather a considerable amount of data that in fact will give us good insight into the risk, particularly in the vaccination of young people in your military,” he told the Israeli broadcaster.
Israel has made vaccination the central plank in its efforts to curb a major resurgence of virus infections after having reduced the daily caseload in June to barely more than a dozen.
While research suggests immunity levels in those who have been vaccinated wane over time — an effect that can be reversed by boosters — the Pfizer-BioNTech vaccine is still highly protective against severe illness and death, even amid the spread of the highly contagious Delta variant.
Of the country’s approximately 9.3 million citizens, 6,123,729 have had a least one vaccination shot, of which 5,643,997 have had the second and 3,439,536 have had three doses. Israel began rolling out the booster shot campaign in late July.
On Friday, Israel’s Health Ministry published figures showing there were 4,313 cases diagnosed the day before, out of over 115,000 people who were tested for the virus.
The number of serious cases, considered a key indicator of the virus outbreak, also dropped, to 607, the lowest level since August 20 when there were 618.
There were 45,4212 active patients in the country, the data showed.
Since the start of the pandemic last year, 1,285,570 people in Israel were diagnosed with COVID-19, and there have been 7,766 deaths from the disease, as of Friday.
The numbers came as Israel emerges from the month-long festival period when officials feared cases would spike due to family gatherings and large prayer services in synagogues. However, the holidays have so far not interrupted a slight downward trend in virus spread over the past week.
Agencies contributed to this report.